RECRUITING

Wearable Sensors to Detect Atypical Muscle Activation in Young Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to see if wearable sensor technology can be used to evaluate muscle activity and/or identify atypical muscle tone in infants up to 48 weeks postmenstrual age (8 weeks corrected age). These sensors are placed on the surface of the skin and record data about a child's body movements and muscle activity.

Official Title

Early Detection of Atypical Neuromuscular Development Using Wearable Sensors and Video: A Comparative Analysis of Muscle and Motion

Quick Facts

Study Start:2025-05-19
Study Completion:2026-05-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06970522

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:0 Months to 8 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * For Infants with low tone:
  2. * Hospitalized in the NICU
  3. * AND \>38 weeks post-menstrual age
  4. * AND abnormal normal brain imaging OR Apgar score \<7 at five minutes with umbilical cord pH (if obtained) \<7.15
  5. * AND 2 or more warning signs for muscle tone or posture using the HNNE short form
  6. * AND legal guardian able and willing to give written consent and comply with study procedures
  7. * For Infants with typical tone:
  8. * Born at 38-41 weeks of gestation
  9. * AND hospitalized after birth in the NICU OR well newborn nursery
  10. * AND infants with appropriate for gestational age birth weight
  11. * AND HNNE exam (short proforma) normal with no warning signs for any parameter
  12. * AND legal guardian able and willing to give written consent and comply with study procedures.
  1. * Infants of Both Low Tone and Typical Tone Cohorts:
  2. * Missing or incomplete limbs (such as from amputation or congenital limb defects).
  3. * Open wounds or skin breakdown on the limbs or torso.
  4. * Presence of known genetic syndrome or congenital anomalies requiring surgery or affecting function
  5. * Use of sedative medications (may include phenobarbital if level stable and therapeutic)
  6. * Legal guardian unable to give written consent and comply with study procedures.
  7. * Does not receive medical clearance from a physician to participate in the study if the individual is receiving inpatient care.

Contacts and Locations

Study Contact

Rachel Andersen
CONTACT
312-238-1476
randersen@sralab.org
Megan O'Brien, PhD
CONTACT
312-238-2289
mobrien02@sralab.org

Principal Investigator

Arun Jayaraman, PT, PhD
PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab

Study Locations (Sites)

Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

  • Arun Jayaraman, PT, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan AbilityLab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19
Study Completion Date2026-05-31

Study Record Updates

Study Start Date2025-05-19
Study Completion Date2026-05-31

Terms related to this study

Keywords Provided by Researchers

  • Early Detection
  • Wearable Sensors

Additional Relevant MeSH Terms

  • Neuromuscular Disorders
  • Motor Development
  • Muscle Tone